deltatrials
Terminated PHASE3 INTERVENTIONAL 4-arm NCT01738698

Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 160mg as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia

Sponsor: Shire

Conditions Schizophrenia
Updated 13 times since 2017 Last updated: May 29, 2021 Started: Nov 1, 2012 Primary completion: Apr 1, 2013 Completion: Apr 1, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.

This PHASE3 trial investigates Schizophrenia and is currently terminated or withdrawn. Shire leads this study, which shows 13 recorded versions since 2012 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~May 2018 · 9 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

13 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Jan 2023 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Dec 2022 — Jan 2023 [monthly]

    Terminated PHASE3

  5. Dec 2021 — Dec 2022 [monthly]

    Terminated PHASE3

Show 8 earlier versions
  1. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  2. Jan 2021 — Sep 2021 [monthly]

    Terminated PHASE3

  3. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  4. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  5. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  6. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  7. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE3

    First recorded

Nov 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shire
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations